(151 days)
This non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.
The subject device in this 510(k) Notification is Iconic Nitrile Glove - Powder Free Nitrile Examination Glove. The subject device is a patient examination glove made from Nitrile compound, Blue color, powder free and non-sterile (Per 21 CFR 880.6250, class I). The device meets the specifications in ASTM D6319-19 Standard specification for Nitrile Examination Gloves. The available sizes of the subject devices are Small, Medium, Large, X-Large.
The provided text describes the acceptance criteria and the results of a study for the "Iconic Nitrile Glove," a non-powdered patient examination glove.
Here's the breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Characteristics/Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Average Results) | Final Status |
|---|---|---|---|---|
| Freedom from hole - ASTM D5151-19 | Freedom from hole | AQL 2.5 | Non sterile (for all sizes: Small, Medium, Large, X-Large) | Pass |
| Dimensions | Overall Length (mm) | Min 230mm | Small: 234.9, Medium: 246, Large: 236.5, X-Large: 241.0 | Pass |
| Dimensions | Width (±10mm) | Small - 80, Medium- 95, Large-110, X-large-120 | Small: 84.7, Medium: 97.4, Large: 106.4, X-Large: 114.6 | Pass |
| Dimensions | Thickness at Palm | Min: 0.05 mm | Small: 0.10, Medium: 0.06, Large: 0.08, X-Large: 0.09 | Pass |
| Dimensions | Thickness at Fingertip | Min: 0.05 mm | Small: 0.12, Medium: 0.10, Large: 0.13, X-Large: 0.13 | Pass |
| ASTM D6319-19 (Before Aging) | Physical properties before aging - Tensile Strength | 14 MPa, min. | Small: 21.2, Medium: 25, Large: 18.9, X-Large: 18.4 | Pass |
| ASTM D6319-19 (Before Aging) | Physical properties before aging - Ultimate Elongation | 500 % min | Small: 896.3, Medium: 893.8, Large: 919.7, X-Large: 930.9 | Pass |
| ASTM D6319-19 (After Accelerated Aging) | Physical properties after accelerated aging - Tensile Strength | 14 MPa, min. | Small: 23.5, Medium: 26.8, Large: 22.2, X-Large: 19.3 | Pass |
| ASTM D6319-19 (After Accelerated Aging) | Physical properties after accelerated aging - Ultimate Elongation | 400 % min | Small: 879.2, Medium: 787.9, Large: 855.3, X-Large: 858.6 | Pass |
| Powder-free Residue - ASTM D6124-06 | Powder-free Residue |
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.